There is an unfortunate tendency to test and release new medications for adults, without any parallel testing in children.  To reverse this, federal research dollars are now accompanied by a policy to require that children be included in experimental populations.  In addition, pharmaceutical firms are now mandated to include children in their drug trials and the firms are rewarded with 6 additional months of exclusive production rights if they do so. 

But is it ethical to put a child on a placebo-controlled drug trial?  The authors of this article interpret federal guidelines on this matter.  Guidelines state that if one of three criteria is met, a placebo-controlled trial may ethically take place.  They are: there must be minimal risk to the child, greater than minimal rise by a  prospect for direct benefit, or the research  must improve the knowledge of the child’s own condition. 

Details of these criteria are: 

(1) Minimal risk: A child should not face a greater risk on the trial medication (or from not treating the medical condition when on a placebo) than risks normally encountered in daily life.    

(2) Greater than minimal risk, but prospect of direct benefit:  The potential for direct benefit must outweigh the risks of the research.  For example, if a child with asthma were on placebo, that placebo must offer a compensating action that is a direct benefit to the child.   

(3) Greater than minimal risk, no prospect of direct benefit, but research likely to produce knowledge of subject’s disorder.

For example a child with depression may be on a trial medication (potential benefit) or a placebo (minor potential risk of untreated depression) if the untreated depression gives doctors information on their patient’s fluctuations of symptoms. 

(Miller FG et al: Journal of Pediatrics 2003; 142:102-107.)

Comment:  Some school teachers and other staff become upset with the medical profession when students are prescribed with “adult medications”, particularly those for aggression and other behaviors.   But there has been little choice for doctors, thus far.  Hopefully new federal policies, even with theses stringent guidelines, will improve on this situation in the future.                         –H.T.